A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
NCT06329661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2025-08-27
Summary
The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)
Conditions
Interventions
- DRUG
-
Cyclosporine ophthalmic solution, 0.1%
Colorless and clear opthalmic solution containing 0.1% Cyclosporine
- DRUG
-
Saline solution, 0.6%
Colorless and clear sodium chloride solution (0.6%)
Sponsors & Collaborators
-
Novaliq GmbH
lead INDUSTRY
Principal Investigators
-
Sonja Krösser, PhD · Novaliq GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-22
- Primary Completion
- 2025-07-30
- Completion
- 2025-07-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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